Post-Authorisation Studies (PAS)

Course attendants will receive examples of safety topics needing a PAS and be requested to prepare a study outline and synopsis. Two of the issues regard safety concerns (one concerning a vaccine), one concerning an efficacy concern and one the need to document the success of a risk minimisation activity. Slides with the highlights of each issues will be presented before the group work. The groups will be asked to present their study outline in plenum. After the presentations and discussion of the proposed studies, the trainer will present the actual solution as presented in the public domain.